4
5
CAUTION
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied
around simultaneously, because this could cause temporary loss of function of those
simultaneously-used monitoring ME equipment.
*On the rare occasion of a fault causing the cuff to remain fully inflated during measurement,
open the cuff immediately. Prolonged high pressure (cuff pressure
＞
300mmHg or constant
pressure
＞
15mmHg for more than 3 minutes) applied to the wrist may lead to an
ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of patient
blood circulation.
* When measurement, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was
clinically investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the
manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant.
Besides providing inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation
and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or
operations.Otherwise, the patient’s wrist and fingers will become anaesthetic, swollen and
even purple due to a lack of blood.
* When not in use, store the device in a dry room and protect it against extreme moisture,
heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer
cannot be held liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe the
storage and operating conditions described in this booklet.
* The maximum temperature that the applied part can be achieved is 42.5
℃
while the
environmental temperature is 40
℃
.
* The equipment is not AP/APG equipment and not suitable for use in the presence of a
flammable anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure, transmit data and change batteries under normal circumstances
and maintain the device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field
radiated interference signal or electrical fast transient/burst signal.
* The blood pressure monitor and the cuff are suitable for use within the patient environment.
If you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been
tested and found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010.
It will not cause any potential sensization or irritation reaction.
* If you experience discomfort during a measurement, such as pain in the wrist or other
complaints, press the START/STOP button to release the air immediately from the cuff.
Loosen the cuff and remove it from your wrist.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should
the cuff not deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the
wrist and press the START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition.
Check the device, do not use the device if it is damaged in any way. The continuous use of a
damaged unit may cause injury, improper results, or serious danger.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage
state. The typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after
maintenance and repair, by retesting at least the requirements in limits of the error of the cuff
pressure indication and air leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to
the local guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists,
descriptions, calibration instructions,etc., to assist to service personnel in parts repair.
* The operator shall not touch output of batteries and the patient simultaneously.
* Cleaning :Dust environment may affect the performance of the unit. Please use the soft cloth
to clean the whole unit before and after use. Don’t use any abrasive or volatile cleaners.
* The device doesn’t need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using, please
contact the SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself in
the event of malfunctions. The device must only be serviced, repaired and opened by
individuals at authorized sales/service centers.
* Please report to Transtek if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing
of small parts. It is dangerous or even fatal.
* Be careful to strangulation due to cables and hoses, particularly due to excessive length.
* At least 30 min required for ME equipment to warm from the minimum storage temperature
between uses until it is ready for intended use. At least 30 min required for ME equipment to
cool from the maximum storage temperature between uses until it is ready for intended use.
* This equipment needs to be installed and put into service in accordance with the information
provided in the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile
phones, cordless telephones and their base stations, walkie-talkies can affect this equipment
and should be kept at least a distance d away from the equipment. The distance d is
caculated by the MANUFACTURER from the 80 MHz to 5.8 GHz column of Table 4 and Table
9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable partes specified/ authorised by MANUFAC-
TURE. Otherwise, it may cause damage to the unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a possibility
that they might be inadvertently connected to intravascular fluid systems, allowing air to be
pumped into a blood vessel.
* Please use the device under the environment which was provided in the user manual.
Otherwise, the performance and lifetime of the device will be impacted and reduced.
CAUTION
INTRODUCTION
INTRODUCTION
